Opioid Sparing Anesthesia Using Ketodex Versus Opioid Based Anesthesia in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 8
- 主要终点
- Total nalbuphine consumption (mg) during the first 24 hours postoperatively.
研究概览
简要总结
comparing Opioid sparing anesthesia using ketodex versus opioid based anesthesia in obese patients undergoing laparoscopic sleeve gastrectomy.
详细描述
Bariatric surgery has seen a substantial increase, especially among patients with medically complex obesity who struggle to lose weight with traditional approaches . Although advances in anesthetic procedures enhance surgical and clinical outcomes, regular opioid usage in bariatric surgeries might result in adverse effects such as drowsiness, postoperative nausea and vomiting (PONV), respiratory depression, and impaired gastrointestinal motility. These adverse effects increase the risk of postoperative cardiac and respiratory complications .
The key to managing such patients is the utilization of a novel form of anesthesia and analgesia, known as opioid-sparing anesthesia, which has recently been developed to ensure better outcomes . During opioid-sparing anesthesia, the sympathetic nervous system is inhibited by means other than opioid delivery . Such techniques include the use of medications from the alpha-2 agonist group, lidocaine, ketamine, magnesium sulfate, beta-blockers, or gabapentinoids .
Ketamine is an N-methyl-D-aspartate antagonist with analgesic and anti-hyperalgesic properties at low doses . This drug prevents the development of opioid tolerance by minimizing opioid use while reducing postoperative pain, ultimately decreasing opioid-related postoperative morbidity .
Dexmedetomidine, a highly selective α2-adrenoceptor agonist, is used as an adjuvant analgesic in the perioperative period . It improves hemodynamic stability and reduces the stress induced by intubation due to its central sympatholytic action . Furthermore, it decreases the need for opioids and anesthetics, providing additional benefits for obese patients .
By lowering the required dosages, adding a low dose of ketamine to dexmedetomidine is thought to result in less toxicity than using either medication alone . Vishnuraj et al. concluded that the combination of ketamine and dexmedetomidine effectively reduced postoperative opioid consumption; however, their approach involved the use of ketamine as a bolus following induction, in conjunction with a continuous infusion of dexmedetomidine in adults undergoing laparoscopic cholecystectomy .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (>18 years) undergoing Elective Bariatric Surgery .
- •American Society of Anesthesiologists physical status class II or III .
- •body mass index (BMI) > 35 kg/m2 .
排除标准
- •• Refusal to participate .
- •Any sensitivity or contraindication to ketamine or dexmedotomidine .
- •Pregnancy or breast feeding .
- •Patients with significant renal impairment .
- •Any patient on regular intake of beta blockers or calcium channel blockers .
- •CNS disorders eg: seizures , raised intra cranial tension .
- •Chronic opioid use.
- •Obese patients with STOP bang score more than 5 .
研究组 & 干预措施
ketodex group
Group KD: Two syringes containing ketodex-ketamine (1 mg/kg) and dexmedetomidine (1 µg/kg)-each diluted with 0.9% saline and infused over 10 minutes. Maintenance will consist of continuous low-dose infusion of ketamine (0.3 mg/kg/h) and dexmedetomidine (0.5 µg/kg/h) in separate syringes until 15 minutes before the end of surgery.
干预措施: ketamine and dexmeditomidine combination (Drug)
opioid based group
Group OP: Two syringes-one containing fentanyl (2 µg/kg) and the other 0.9% saline-infused over 10 minutes. Maintenance will be provided by two continuous saline infusions, prepared to mimic the ketodex infusions, until 15 minutes before the end of surgery.
干预措施: Fentanyl (IV) (Drug)
结局指标
主要结局
Total nalbuphine consumption (mg) during the first 24 hours postoperatively.
时间窗: during the first 24 hours postoperatively
Total nalbuphine consumption (mg) during the first 24 hours postoperatively.
次要结局
- Postoperative sedation scores.(1st 24 hours postoperatively)
- Total intraoperative titrated fentanyl dose for each patient.(intraoperative time)
- Time to extubation, defined as the interval between discontinuation of anesthesia and tracheal extubation(the interval between discontinuation of anesthesia and tracheal extubation)
- • Time to first postoperative rescue analgesia(during 1st 24 hrs postoperatively.)
- Postoperative pain scores assessed using the Numerical Rating Scale (NRS).(1st 24 hours post operatively)
- Postoperative nausea and vomiting (PONV) scores(1st 24 hours postoperatively)
- Patient satisfaction scores .(during 1st 24 hours postoperatively.)
- Length of hospital stay(1-2 weeks)
研究者
Mai younes Taha
lecturer of anesthesia , cairo university
Cairo University